Effect of intensive blood pressure control on cognitive outcomes and brain structures in adults with type 2 diabetes: prespecified analysis of secondary outcomes of BPROAD randomised controlled trial
Primary result · Composite of all cause dementia or mild cognitive impairmentResult — go to the resultHazard ratio 0.96 95% CI 0.86–1.06Authors' conclusion
Over a median of about four years, no statistically significant difference in incidence of a composite of all cause dementia or mild cognitive impairment was observed among adults with type 2 diabetes receiving standard treatment of SBP (target <140 mm Hg) and intensive treatment (target <120 mm Hg). Intensive treatment was, however, associated with a reduction in the accrual of cerebral white matter lesion volume.
Study context
- Population
- Adults aged ≥50 years with type 2 diabetes, raised systolic blood pressure (SBP), and increased cardiovascular risk, without probable dementia at baseline; 145 clinical centres across seven geographical regions in Chinawithout probable dementia at baseline, included in the cognitive ancillary study (of 12,821 in the trial) · magnetic resonance imaging (MRI) at baseline 862 · MRI at end of study 605
- Participants
- 12,434 adults
- Comparison
- Intensive treatment targeting SBP <120 mm Hg vs standard treatment targeting SBP <140 mm Hg for up to five years
- INTENSIVEn = 6,219
- STANDARDn = 6,215reference
- Primary endpoint
- Composite of:
- All cause dementia
- Mild cognitive impairment
- Follow-up
- Median 3.8 years
Methodological detailsprespecified analysis of secondary outcomes, cognitive ancillary study
- Prespecified analysis of secondary outcomes
- Cognitive ancillary study
Primary result
As reported in the abstract
Hazard ratio
0.96
95% CI 0.86–1.06
P = 0.38
Events by treatment group
INTENSIVE
3.69 events per 100 person years
747 of 6219
STANDARD
3.89 events per 100 person years
783 of 6215
Further findings
| Outcome | Between group difference (inverse hyperbolic sine (asinh) transformed cm³) (95% CI) | P value | |
|---|---|---|---|
| Increase in white matter lesion volume (MRI substudy) | −0.09 (−0.15 to −0.02) | P = 0.01 | |
| −0.2−0.100.1Difference, inverse hyperbolic sine (asinh) transformed cm³ (linear scale) |
Mean SBP · after one year
- Increase in white matter lesion volume (MRI substudy): smaller increase with intensive treatment; MRI substudy 428 intensive v 434 standard
Baseline characteristics
- Baseline mean age
- 63.7 years
- Women
- 5567 (44.8%)
Original publication
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